1. Field of the Invention
Embodiments of the present invention relate generally to methods for the characterization of the responsiveness of an individual to certain therapeutic agents. More specifically, embodiments disclosed herein relate to the prediction of the whether an individual will respond or fail to respond to interferon (IFN) therapy in certain disease contexts, including cancer and/or hepatitis therapy. Certain embodiments relate to methods of monitoring the effectiveness of ongoing IFN therapy in an individual.
2. Description of the Related Art
Interferons are anti-viral drugs used in laboratory research settings, as well as clinically, to combat viral infections and/or in therapies for indications such as cancer. It is clinically approved for treatment of hepatitis B and C as well as a variety of cancers, including certain leukemias, myelomas, and melanomas.
Hepatitis is a viral liver disease characterized by the presence of inflammatory cells in the liver. While there are many causes of the disease (including exposure to infectious blood or body fluids, unprotected sexual contact, blood transfusions, use of contaminated needles, and vertical transmission from mother to child during childbirth), diagnosis is challenging because viral antigens may not appear until well after initiation of the infection. Hepatitis also exists in many forms, most prominently Hepatitis B (caused by the hepatitis B virus, “HBV”) and Hepatitis C (caused by the hepatitis C virus “HCV”). Both of these forms of Hepatitis may either be acute (less than six months to resolution) or chronic (infection greater than six months).
Both HBV and HCV exist in various genetic subtypes, which affect the severity of the disease symptoms, the likelihood of complications, and the possible responsiveness of the host to various available treatments, of which interferon therapy one.
IFN has anti-proliferative, pro-apoptotic, and anti-angiogenic effects on cultured cancer cells, but the particular molecular targets and mechanisms triggered by exogenous IFN remain under investigation. Moreover, the variety of etiologies that underlie cancers may limit the efficacy of a single therapeutic agent or regime against more than a few related types of cancer.
Despite its current clinical use, there remains a need for assessing the likelihood that a given individual will respond positively to IFN administration. There is also a need for monitoring the ongoing efficacy of IFN administration in an individual receiving the IFN on an ongoing basis.